Otsuka Chemical Co Ltd Discontinued
FDA Approved Drugs
Otsuka Chemical Co Ltd Discontinued
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 20
- Latest Approval Date Nov 13, 2017
- Data Source FDA
- First Approval Date Oct 14, 1997
Company Overview
Company
Otsuka Chemical Co Ltd Discontinued
Country
Japan
Website
Social Profiles
Company Snapshot
Otsuka Chemical Co Ltd Discontinued
3-2-27, Ote-Dori, Chuo-Ku, Osaka, 540-0021
Japan
www.otsukac.co.jp:443/ yuichiro-shibata@otsukac.co.jp View on MapFDA Approved Drug Records ( 20 records )
Drug Name
ABILIFY
Product Number
1
Dosage Form
-
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-10
Active Ingredient
ARIPIPRAZOLE
Application Number
21713
Product Number
1
Dosage Form
-
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-12-10
Regulatory Status
Discontinued
Drug Name
ABILIFY
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Active Ingredient
ARIPIPRAZOLE
Application Number
21729
Product Number
2
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Regulatory Status
Discontinued
Drug Name
ABILIFY
Product Number
3
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Active Ingredient
ARIPIPRAZOLE
Application Number
21729
Product Number
3
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Regulatory Status
Discontinued
Drug Name
ABILIFY
Product Number
4
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Active Ingredient
ARIPIPRAZOLE
Application Number
21729
Product Number
4
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Regulatory Status
Discontinued
Drug Name
ABILIFY
Product Number
5
Dosage Form
-
Strength
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Active Ingredient
ARIPIPRAZOLE
Application Number
21729
Product Number
5
Dosage Form
-
Strength
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-06-07
Regulatory Status
Discontinued
Drug Name
ABILIFY
Product Number
1
Dosage Form
-
Strength
9.75MG/1.3ML (7.5MG/ML)
Approval Date
2006-09-20
Active Ingredient
ARIPIPRAZOLE
Application Number
21866
Product Number
1
Dosage Form
-
Strength
9.75MG/1.3ML (7.5MG/ML)
Approval Date
2006-09-20
Regulatory Status
Discontinued
Drug Name
ABILIFY MYCITE KIT
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2017-11-13
Active Ingredient
ARIPIPRAZOLE
Application Number
207202
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
ABILIFY MYCITE KIT
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2017-11-13
Active Ingredient
ARIPIPRAZOLE
Application Number
207202
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
ABILIFY MYCITE KIT
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2017-11-13
Active Ingredient
ARIPIPRAZOLE
Application Number
207202
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
ABILIFY MYCITE KIT
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2017-11-13
Active Ingredient
ARIPIPRAZOLE
Application Number
207202
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
ABILIFY MYCITE KIT
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2017-11-13
Active Ingredient
ARIPIPRAZOLE
Application Number
207202
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
ABILIFY MYCITE KIT
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2017-11-13
Active Ingredient
ARIPIPRAZOLE
Application Number
207202
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
DACOGEN
Product Number
1
Dosage Form
-
Strength
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-05-02
Active Ingredient
DECITABINE
Application Number
21790
Product Number
1
Dosage Form
-
Strength
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-05-02
Regulatory Status
Discontinued
Drug Name
FERRISELTZ
Product Number
1
Dosage Form
-
Strength
600MG/PACKET
Approval Date
1997-10-14
Active Ingredient
FERRIC AMMONIUM CITRATE
Application Number
20292
Product Number
1
Dosage Form
-
Strength
600MG/PACKET
Approval Date
1997-10-14
Regulatory Status
Discontinued
Drug Name
PLETAL
Product Number
1
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-15
Active Ingredient
CILOSTAZOL
Application Number
20863
Product Number
1
Dosage Form
-
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-15
Regulatory Status
Discontinued
Drug Name
PLETAL
Product Number
2
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-15
Active Ingredient
CILOSTAZOL
Application Number
20863
Product Number
2
Dosage Form
-
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-01-15
Regulatory Status
Discontinued
Drug Name
RAXAR
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
1997-11-06
Active Ingredient
GREPAFLOXACIN HYDROCHLORIDE
Application Number
20695
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
1997-11-06
Regulatory Status
Discontinued
Drug Name
RAXAR
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
1998-05-14
Active Ingredient
GREPAFLOXACIN HYDROCHLORIDE
Application Number
20695
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
1998-05-14
Regulatory Status
Discontinued
Drug Name
RAXAR
Product Number
3
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
1998-05-14
Active Ingredient
GREPAFLOXACIN HYDROCHLORIDE
Application Number
20695
Product Number
3
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
1998-05-14
Regulatory Status
Discontinued
Drug Name
SAMSCA
Product Number
3
Dosage Form
-
Strength
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2009-05-19
Active Ingredient
TOLVAPTAN
Application Number
22275
Product Number
3
Dosage Form
-
Strength
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2009-05-19
Regulatory Status
Discontinued
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Drug Status Breakdown
20 total- Discontinued
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
ABILIFY
Application Number
21713
Product Number
1
Active Ingredient
ARIPIPRAZOLE
Dosage Form
-
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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